Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Study Description

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Brief Summary:

This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.

Condition or disease	Intervention/treatment	Phase
Cancer Survivor; Prevention of Human Papillomavirus Infection	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58); Other: laboratory biomarker analysis; Other: survey administration; Other: medical chart review	Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.

II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.

III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.

OUTLINE:

AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.

AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1268 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
Study Start Date :	July 2012
Estimated Primary Completion Date :	January 2019
Estimated Study Completion Date :	July 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Prevention (vaccine therapy); Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58); Given IM; Other Names: Gardasil; Gardasil 9 Other: laboratory biomarker analysis; Correlative studies Other: survey administration; Ancillary studies Other: medical chart review; Ancillary studies; Other Name: chart review

Outcome Measures

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Primary Outcome Measures :

1. Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ]
   To estimate the prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years and to examine the sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
2. Immunogenicity of the HPV vaccine in cancer survivors (anti-HPV 6 and 11 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ]
   To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
3. Safety/tolerability of the HPV vaccine in cancer survivors (Aim 2 [vaccine evaluation]) [ Time Frame: Through 7-14 days following last vaccine dose ]
   To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population

Eligibility Criteria

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Ages Eligible for Study:	9 Years to 26 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• AIM 1 (SURVEY) (AIM 1 is closed to enrollment)
• Cancer survivor
• Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant [HCT])
• Scheduled for a return clinic visit at one of the participating institutions
• English or Spanish-speaking
• Willing to provide informed consent/assent for study participation
• AIM 2 (VACCINE EVALUATION)
• Meets all inclusion criteria outlined in Aim 1
• Survey response indicated no prior history of HPV vaccination OR patient has no prior history of HPV vaccination by self - or parent/caregiver-report
• English or Spanish-speaking
• Medical clearance from treating clinician for study participation
• Agrees to return to participating institution for 3 HPV vaccine injections
• Willing to provide informed consent/assent for study participation

Exclusion Criteria:

• AIM 2 (VACCINE EVALUATION)
• Allergy to any component of the HPV vaccine including yeast and aluminum
• Thrombocytopenia (platelet count < 50K) or coagulation disorder that would contraindicate intramuscular injection
• Transfusion of blood products or intravenous immune globulin within 3 months of study entry
• Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Wendy Landier, PhD, CRNP 205-638-2120 wlandier@peds.uab.edu
Principal Investigator: Wendy Landier, PhD, CRNP
United States, California
City of Hope Medical Center	Active, not recruiting
Duarte, California, United States, 91010
United States, Georgia
Emory University School Of Medicine	Recruiting
Atlanta, Georgia, United States, 30308
Contact: Karen Wasilewski-Masker, MD 404-536-5747 karen.wasilewski@choa.org
Principal Investigator: Karen Wasilewski-Masker, MD
United States, Michigan
University of Michigan	Active, not recruiting
Ann Arbor, Michigan, United States, 48109
United States, Tennessee
Saint Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Contact: James Klosky, PhD 901-595-5057 james.klosky@stjude.org
Principal Investigator: James Klosky, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

National Cancer Institute (NCI)

Merck Sharp & Dohme Corp.

Investigators

Principal Investigator:	Wendy Landier, PhD, CRNP	University of Alabama at Birmingham

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Wendy Landier, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01492582 History of Changes
Other Study ID Numbers:	UAB-F141204009/UAB-X141204010; NCI-2011-03654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 1R01CA166559 ( U.S. NIH Grant/Contract ); Merck-IISP#40083 ( Other Identifier: Merck & Co. ); COH-11034 ( Other Identifier: City of Hope IRB )
First Posted:	December 15, 2011
Last Update Posted:	October 16, 2017
Last Verified:	October 2017

Additional relevant MeSH terms:

Infection; Papillomavirus Infections; DNA Virus Infections; Virus Diseases	Tumor Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs